Transarterial Ethanol Ablation(TEA) for Unresectable Hepatocellular Carcinoma(HCC)

The Chinese University of Hong Kong

Status: Completed

Conditions: Hepatocellular Carcinoma

Treatments: Procedure: TEA

Study type: Interventional

Funder types: Other

Identifiers

NCT01837381

VIR-13-03

Details and patient eligibility

About

The objective of this trial was to evaluate the clinical outcome, treatment toxicity and tumor response of TEA for unresectable HCC.

Full description

Transarterial therapy has been playing an important role in the treatment algorithm for patients with multifocal or large intrahepatic lesions not eligible for surgical resection, transplantation, or local ablative therapy. Among the various options of transarterial therapy including chemoembolization (TACE), bland embolization, radioembolization, and TEA, chemoembolization is the only one that has been proven to be of survival benefits versus best supportive care in randomized controlled trials. TEA is a hybrid of bland embolization and chemical ablation. Utilizing a liquid agent of Lipiodol-ethanol mixture consisting of 33% ethanol by volume, TEA offers complete and long lasting embolization of both the arterioles and portal venules supplying the tumor and could possibly be more effective than particulate embolic agents in tumor vessel embolization. The component of ethanol very likely offers synergistic effect to embolization and causes tumor ablation.

Enrollment: 200 patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• Signed informed consent by patient
• Age above 18 years
• Child-Pugh A or B cirrhosis
• Eastern Cooperative Oncology Group(ECOG) performance score 2 or below
• No serious concurrent medical illness
• No prior treatment or surgery for HCC
• Histologically or cytologically proven HCC except for lesions of size 1 to 2 cm, with typical features of HCC on two dynamic imaging techniques, or lesions larger than 2cm, with typical features on one dynamic imaging techniques, or lesions larger than 2cm with alpha feto protein(AFP) level > 200 ng/mL
• Unresectable disease without extra-hepatic involvement on chest X-ray(CXR) and CT
• Massive expansive tumor type with measurable lesion on CT
• Total tumor mass < 50% liver volume
• Tumor size ≤ 15cm in largest dimension
• Tumor number ≤ 5

Exclusion criteria

• History of prior malignancy except on the condition that the patient has been disease free for ≥ 3 years
• Concurrent ischemic heart disease or heart failure
• History of acute tumor rupture presenting with hemo-peritoneum
• Serum creatinine level > 180 umol/L
• Biliary obstruction not amenable to percutaneous drainage
• Child-Pugh C cirrhosis
• History of hepatic encephalopathy
• Intractable ascites not controllable by medical therapy
• History of variceal bleeding within last 3 months; serum total bilirubin level ≥ 50 umol/L
• Serum albumin level < 25g/L
• International normalized ratio(INR) > 1.5
• Extrahepatic metastasis
• Infiltrative or diffuse tumor
• Tumor number > 5
• Thrombosis of target hepatic artery
• Partial or complete thrombosis of the main portal vein; tumor invasion of portal branch of contralateral lobe
• Hepatic vein tumor thrombus
• Significant arterio-portal venous shunt
• Significant arterial-hepatic venous shunt

Trial design

Primary purpose: Treatment

Allocation: N/A

Interventional model: Single Group Assignment

Masking: None (Open label)

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200 participants in 1 patient group

Transarterial Ethanol Ablation (TEA)

Other group

Description:

Two treatment sessions at 2 months apart were given and started within 4 weeks after randomization.

Treatment:

Procedure: TEA